Devices and methods for nasal splinting

ABSTRACT

A nasal splint and methods for using such splints are provided. The nasal splint may include an elongate generally planar member comprising first and second ends, and a first outer surface and an opposite second outer surface; a tubular airway extending along the first outer surface at least partially between the first and second ends, thereby defining a lumen having an opening adjacent the first end; and a structure on one of the elongate member and tubular airway adjacent the first end supporting a feature that is spaced apart from the first outer surface and configured to support a suture across the opening when the suture is directed through the elongate member adjacent the first end and the feature.

RELATED APPLICATION DATA

This application is a continuation of co-pending InternationalApplication No. PCT/US2014/045816, filed Jul. 8, 2014, which claimsbenefit of provisional application Ser. No. 61/843,841, filed Jul. 8,2013, the entire disclosures of which are expressly incorporated byreference herein.

FIELD OF THE INVENTION

The present invention relates to devices and methods for performingsurgical procedures, and more particularly to splint devices and methodsfor performing septoplasty and/or other nasal surgery, which mayinvolving locating and/or removing one or more sutures.

BACKGROUND

The use of splints and other reinforcing materials to maintain theposition of tissues following surgery is a common technique in medicine.These structures are often secured in position using a suture tied tothe surrounding tissue or tissues. Thin gauge suture material is used tominimize scarring and disruption to the anchoring tissue. Whilesuccessful in doing so, the use of small-diameter suture material canintroduce some difficulties when the splints are to be removed duringthe course of a patient's recovery. Thin suture material can bedifficult to identify and isolate at the healing surgical site, leadingto a potentially painful and cumbersome excavation procedure (patientsare awake at the follow-up visits when the splints or reinforcingmaterials are removed). The devices and methods describe herein maysimplify the identification and cutting of suture materials used to fixsplints, stents, reinforcing materials, and the like in position at asurgical site.

As an example, septoplasty, or the surgical correction of problems ofthe nasal septum, is a procedure commonly performed to address a numberof issues that can affect the quality of a patient's life. For example,the procedure may involve repairing a defect to the septum that ispartially or fully occluding the airways in the nose (e.g., a deviatedseptum, in which the nasal septum does not equally divide the nasalcavity into two halves), uncontrollable nosebleeds, and to repair a holein the nasal septum (i.e., a nasal perforation).

To perform a septoplasty, a surgeon generally makes an incision on oneside of the nasal septum, lift the mucus membrane that covers the septumoff of the cartilage and/or bone of the nasal septum, remove, modify, ormove the structures of the nasal septum that are causing the patient'ssymptoms, and replace the mucus membrane over the surgically-alteredstructure of the nasal septum. The membrane may be held in place usingsutures, splints, packing materials, or a combination thereof.

The maintenance of a midline orientation of the septum (dividing thenasal cavity into two approximately equal halves) is the prime goalfollowing septoplasty. Nasal splints are commonly used to achieve thisend. The placement of a splint on each side of the septum keeps italigned during the critical healing period immediately followingsurgery. These splints are typically shaped and sized to support theseptum and provide a clear airway during the recovery period, and aresupplied in pairs (each individual unit configured for placement on theright or left side of the nasal septum). Splints of this nature aretypically sutured to the nasal septum through the proximal end of thesplints. One suture is used to bind both splints to the nasal septum;this is done by passing a suture needle through one splint, startingfrom the face situated away from the septum, through the septum, throughthe second splint on the other side of the septum, and back through theseptum proximal to the splints. The two free ends of the suture are thentied off to maintain the position of the splints with respect to thenasal septum, while the size and structure of the splints maintain theposition of the nasal septum with respect to the nasal cavity.

A common commercially available nasal splint is the Doyle splint. Thebasic design of the Doyle splint is disclosed in U.S. Pat. No. 3,935,859and remains one of the most used nasal splints following septoplasty.The Doyle splint includes a flat plate contoured to accommodate thenasal septum and an integral tube running the length of the flat plateopposite to the side of the plate that would rest against the nasalseptum. The top edge of the plate has a convex curve and the bottom edgeof the plate is slightly concave. The anterior and posterior ends of theplate are rounded to provide ease of insertion and patient comfort. Thetube extends almost the full length of the splint and provides apassageway for airflow.

The anterior ends of a pair of Doyle splints are typically sutured tothe nasal septum after placement against the surgically repaired nasalseptum (one splint on each side of the septum). Once the position of theDoyle splints has been secured with the suture, the spaces surroundingthe splint are sometimes packed with gauze or other materials to fullysupport the septum. The presence of the tube allows the patient tobreath while the packing material is resident.

Variations of the Doyle splint include the Breeze Nasal Airway Splint(Summit Medical), the Nasal Airway Splint, Doyle Open Lumen Splint,Doyle Combo Splint (Boston Medical Products), and the Doyle Bi-ValveAirway Splint (Medtronic), which add or change features of the originalDoyle splint, but all are sutured into position in a similar fashionafter placement. Other nasal splint designs exist that eliminate thetube feature of the Doyle-style splints, add pre-formed holes intendedto facilitate placement of the suture, and/or change the geometry of theflat plate, but these too require fixation with a suture after thesplint is placed in the patient.

The use of a suture to secure the position of existing splints may causedifficulties when the splints are removed at a post-surgical follow-upexam. At a typical follow up visit, the surgeon cuts the suture holdingor securing the splints against the septum. This procedure can bedifficult to perform while the patient is awake as the post-surgicalmucosal surfaces of the nasal cavity may be very sensitive to touch.Patients often move while the surgeon is attempting to locate andcut/release the suture. The procedure is further complicated by thetight apposition of the splint to the septum. Finding the suture can bedifficult due to the small diameter or gage of the suture material thatis typically used in these procedures (e.g., 3-0 silk) and the presenceof encrustations of dried mucus and blood that can cover and obscure thesuture site. Once found, positioning the surgical scissors to cut thesuture without harming or causing discomfort to the patient can be adifficult and time-consuming task.

While existing nasal splints serve the purpose of supporting the septumand maintaining an open airway to the nasal cavity, there is a need foran intranasal splint that facilitates locating and cutting a stabilizingsuture at the time of removal.

SUMMARY

The present invention is directed to devices and methods for performingsurgical procedures, and more particularly to splint devices forperforming septoplasty and/or other nasal surgery that may involvelocating, cutting, and/or otherwise removing one or more sutures.

In accordance with one embodiment, a nasal splint is provided thatincludes a member having a first outer planar surface and an oppositesecond outer planar surface separated by a wall; a tubular airwayconnected to the first outer planar surface on a line substantiallyparallel to a longitudinal axis extending from a first end of the memberto a second end of the member; an aperture located proximal to the firstend of the member; a structure located proximal to the first end of themember, wherein the structure is configured to provide a space between asuture and the first outer planar surface of the member, and along thelength where the suture traverses between the aperture and thestructure.

The member, tubular airway, and structure may be fabricated as oneintegrated part or may be fabricated separately and joined togetherusing methods known in the art, such as one or more of injectionmolding, casting, over-molding, welding, ultrasonic welding, adhesivebonding, solvent bolding, combinations thereof, and the like. Thetubular member may also include at least one lumen extending from thefirst end to the second end of the tubular member if desired. The memberand tubular airway may be constructed of materials known in the art,e.g., including one or more of medical grade silicone,polytetrafluoroethylene, polyethylene terephthalate, polyether etherketone, polyamide, polyoxymethylene (acetal), polyether block amide,polyurethane, polypropylene, polyvinyl chloride, polyester, combinationsthereof, and the like. The structure may be of equal or greaterstiffness than the member and/or tubular airway, and may be fabricatedfrom materials known in the art, e.g., including one or more of medicalgrade silicone, polytetrafluoroethylene, polyethylene terephthalate,polyether ether ketone, polyamide, polyoxymethylene, polyether blockamide, polyurethane, polypropylene, polyvinyl chloride, polyester,polycarbonate, acrylic, acrylonitrile butadiene styrene, natural rubber,stainless steel, titanium, nickel, platinum, combinations or alloysthereof, and the like.

In an exemplary embodiment, the structure may have a shape that issubstantially circular with a given length or ring-shaped.Alternatively, the structure may be non-circular or irregularly shaped,and/or may be shaped to substantially match and/or conform to the shapeof the airway. The structure may also include two holes located atopposite sides of the ring (e.g., offset one hundred eighty degrees(180°) away from each other). The holes may be sized such that a sutureneedle may pass through each of the holes. The structure may be alignedconcentrically with the distal (or anterior) end of the tubular airwaysuch that the structure is aligned along the interior wall of thetubular airway and the lumen of the ring communicates with the lumen ofthe tubular airway.

The structure may be joined to the tubular airway by methods known tothe art including one or more of press fitting, welding, casting,over-molding (e.g., the tubular airway and member are over-molded aroundthe structure), adhesive bonding, combinations thereof, and the like.The structure may be radially aligned such that a line drawn through thefirst and second holes is perpendicular to the plane of the member, withthe first hole adjacent to the member and the second hole adjacent tothe wall of the tubular airway opposite the first hole. While thisexample describes holes arranged in a single specific manner, it shouldbe clear to one of skill in the art that the holes may be arranged atany location in or around the structure. Furthermore, it should be clearto one of skill in the art that the number of holes in the structure isnot limited to two, and the holes may be of different or identicalshapes and sizes. For example, the first hole may be a channel arrangedparallel or perpendicular to the longitudinal axis of the member and thesecond hole may be substantially circular. It should be clear that othersizes, shapes, orientation, and locations of the holes in the structuremay be included in the devices described herein.

In a typical procedure, two symmetrical splints are used to stabilizeand support the nasal septum. In the procedure, a suture needle withsuture is inserted through the first and second holes in the structureand then through the member of the first splint. The suture needle withsuture then pierces through the patient's nasal septum and exits on thefar side of the nasal septum. The suture needle with suture then passesthrough the member of the second splint and then continues through thesecond and first holes of the structure of the second splint. Then, thesuture needle with suture may then be passed back through the distal endof the member of the second splint across the nasal septum and throughthe distal end of the member of the first splint to be tied off and/orotherwise secured.

Alternatively, if only one splint is used, a suture needle with sutureis inserted through the first and second holes in the structure and thenthrough the member of the first splint. The suture needle with suturethen pierces through the patient's nasal septum and exits on the farside of the nasal septum. Then, the suture needle with suture may bepassed back through the nasal septum and through the distal end of themember of the first splint to be tied off and/or otherwise secured.

In the above described procedural steps using any of the embodiments ofthe devices described herein, the suture is suspended in the lumen ofthe tubular airway of the splint(s) to allow easy access with surgicalscissors or any other cutting tools or instruments to facilitate simplesplint removal. The stiffness of the structure may be such that when thesuture is tightened and tied off, the tubular airway remains patent(i.e., is not constricted or closed off). In another example, additionalholes may be pre-formed or placed in the wall of the tubular airway andmember that align with the holes in the structure to ease placement ofthe suture. These holes may be fabricated using methods known in theart, e.g., including one or more of mechanical cutting and/or drilling,melting, laser cutting, mechanical punching, casting, injection molding(e.g., formed in the same mold as the member and tubular airway),combinations thereof, and the like.

Alternatively, the lumen of the structure may remain concentricallyaligned with the lumen of the tubular airway yet offset a given distanceproximal or distal to the distal end of the tubular airway. In the casethat the structure is distally offset from the distal end of the tubularmember, the structure may be joined to the member using methods known inthe art, e.g., including one or more of welding, casting, over-molding(e.g., the tubular airway and member may be over-molded around thestructure), adhesive bonding, combinations thereof, and the like.

In yet another example, the structure may have other geometriesincluding one or more of arcs, hooks, ellipses, rectilinear shapes,combinations thereof, and the like. Furthermore, the structure may besized to be smaller or larger than the lumen of the tubular airwayand/or not concentrically aligned with the tubular airway. In oneexample, the structure may be substantially circular in geometry withtwo opposed holes as previously disclosed, but smaller in size than thelumen of the tubular airway and tangent to and in contact with themember.

In another embodiment, a hook may be anchored in the wall and/orextending into the lumen of the structure instead of the second hole inthe structure. For illustrative purposes, the structure is assumed to besubstantially circular in shape, however, it should be clear to one ofskill in the art that the structure may assume other geometries. Thehook may be oriented with the open portion of the hook facing towardsthe top of the structure. In this embodiment, the suture may be loopedover the hook instead of passed through the wall of the tubular airwayand the second hole in the structure. The hook feature may provide theoperator with a quicker method for placing the suture and/or maysimplify the procedure. It should be noted that all previously disclosedaspects are contemplated for this embodiment.

In yet another embodiment, the structure may include a tubular passageincluding a distal and proximal end and at least one lumen extendedtherethrough joined to the distal edge of the tubular airway. Thetubular passage may be of equal or greater stiffness than the memberand/or tubular airway, and may be fabricated from materials known in theart, e.g., including one or more of medical grade silicone,polytetrafluoroethylene, polyethylene terephthalate, polyether etherketone, polyamide, polyoxymethylene, polyether block amide,polyurethane, polypropylene, polyvinyl chloride, polyester,polycarbonate, acrylic, acrylonitrile butadiene styrene, natural rubber,stainless steel, titanium, nickel, platinum, combinations or alloysthereof, and the like. The tubular passage may be connected to thetubular airway using methods known to the art including one or more ofpress fitting, welding, casting, over-molding (e.g., the tubular airwayand member may be over-molded around the structure), adhesive bonding,combinations thereof, and the like. The tubular passage may furtherextend along the perimeter of the distal edge of the tubular airway. Theinternal diameter of the tubular passage may be sized to accept standardsizes of suture needles.

For example, if the cross section of the tubular airway is D-shaped withthe flat edge of the “D” shape coincident to the surface of the member,the tubular passage may be an arc starting at the start of the midpointof the curved portion of the “D,” extending upward along the edge of thetubular airway to the top of the “D” and terminating substantiallyperpendicular to the flat edge of the “D.” A suture needle may beinserted in the entrance of the tubular member and advanced through andexit the tubular member, pierce the wall of the tubular airway andmember, and pass through and exit the nasal septum.

If desired, the suture may be passed through a second symmetricalversion of this embodiment on the opposite nasal passage (i.e.,traversing the member, wall of the tubular airway, the tubular passage,and the lumen of the tubular airway). The needle may then be passed backthrough the member of the second splint, the nasal septum, and themember of the first nasal splint distal to the structure and tied off,e.g., to suspend the suture thread in the middle of the tubular airwaysof the first and second splints. Either one or both of the tubularairway and member may also include one or more holes or apertures tofacilitate the passage of the suture needle and subsequent securing ofthe device to the nasal septum.

The tubular passage of this embodiment may be a continuous closedpassage, or may be a series of rings or braces of other geometries. Forexample, the tubular passage may be a single ring that is of a lengthconsiderably shorter than the perimeter of a cross-section of thetubular airway. Furthermore, the tubular passage may be a ridge orcurved segment that does not close completely at all points along thelength of the tubular passage. As an example, the tubular passage maydefine an arc of about two hundred seventy degrees (270°) in crosssection. In another example the tubular passage may define an arc ofabout two hundred seventy degrees (270°) in cross section with one ormore segments that are a circle in cross section.

While some of the preceding examples have described the tubular airwayas a member with a lumen, it should be clear that the features of thedevices described herein are equally applicable to other splinting orstenting configurations. For example, the tubular airway may be a flangethat is affixed to and aligned substantially parallel to thelongitudinal axis of the member, and in cross section forms an arc thatcurves down and away from the member until the lower portion of theflange is substantially parallel to the face of the member.

Another embodiment of a nasal splint that is contemplated is a memberhaving a first outer planar surface and an opposite second outer planarsurface. This member may be placed between tissues to prevent theformation of adhesions and/or to support said tissues during the healingperiod. The structures previously described may be combined with themember to allow for easier location and cutting of a suture thread.

In accordance with an exemplary embodiment, a nasal splint is providedthat includes an elongate generally planar member comprising first andsecond ends, and a first outer surface and an opposite second outersurface extending between the first and second ends; a tubular airwayextending along the first outer surface at least partially between thefirst and second ends, thereby defining an airway lumen having anopening adjacent the first end; and a protrusion extending from thetubular airway adjacent the first end such that a free end of theprotrusion is spaced apart from the first outer surface to support asuture at least partially across the opening when the suture is directedthrough the elongate member.

Optionally, the free end of the protrusion may include one of a hole, ahook, and a weakened region to receive a needle and suture therethrough.In addition or alternatively, the first end of the elongate membercomprises a hole or weakened region adjacent the protrusion to receive asuture therethrough such that the suture extends across the lumenbetween the hole or weakened region and the protrusion.

In accordance with another embodiment, a nasal splint is provided thatincludes an elongate generally planar member comprising first and secondends, and a first outer surface and an opposite second outer surfaceextending between the first and second ends; a tubular airway extendingalong the first outer surface at least partially between the first andsecond ends, thereby defining a lumen having an opening adjacent thefirst end; and a bracket extending from one of the elongate member andtubular airway adjacent the first end and one of a hole and a weakenedregion on the bracket disposed adjacent the opening and spaced apartfrom the first outer surface to support a suture at least partiallyacross the opening when the suture is directed through the elongatemember and through the one of a hole and a weakened region.

In accordance with still another embodiment, a nasal splint is providedthat includes an elongate generally planar member comprising first andsecond ends, and a first outer surface and an opposite second outersurface extending between the first and second ends; a tubular airwayextending along the first outer surface at least partially between thefirst and second ends, thereby defining a lumen having an openingadjacent the first end; and a hook extending from one of the elongatemember and tubular airway adjacent the first end, the hook disposedadjacent the opening and spaced apart from the first outer surface tosupport a suture at least partially across the opening when the sutureis directed through the elongate member and the hook.

In accordance with yet another embodiment, a method is provided fortreating a patient that includes inserting a nasal splint into thepatient's sinus, the nasal splint comprising an elongate planar memberand an airway lumen extending along a first surface of the elongatemember; positioning a second surface of the elongate member against thesinus septum such that the airway lumen extends along the patient'ssinus; and directing a suture through the patient's septum, the elongatemember, and a structure on the nasal splint such that the suture extendsacross a portion of the airway lumen.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is best understood from the following detailed descriptionwhen read in conjunction with the accompanying drawings. It isemphasized that, according to common practice, the various features ofthe drawings are not to scale. On the contrary, the dimensions ofvarious features are arbitrarily expanded or reduced for clarity.Included in the drawings are the following figures:

FIG. 1 is a perspective view of any exemplary embodiment of a nasalsplint.

FIG. 2 is a detailed view of a distal section of the nasal splint shownin FIG. 1.

FIGS. 3A and 3B are cross-sectional details of the distal section of thenasal splint shown in FIGS. 1 and 2.

FIGS. 4A and 4B are perspective views of a distal section of alternativeembodiments of a nasal splint similar to that shown in FIG. 1.

FIGS. 5A-5I are cross-sectional views of alternative embodiments of astructure subcomponent that may be included in a nasal splint.

FIGS. 6A and 6B show perspective views of a distal section ofalternative embodiments of a nasal splint.

FIG. 7A is a perspective view of a distal section of another exemplaryembodiment of a nasal splint.

FIGS. 7B and 7C are front and side view of a structure that be includedin the nasal splint shown in FIG. 7A.

FIGS. 8A-8D are top views showing a method for securing two splints to anasal septum of a patient.

FIG. 8E is a top view of splints from the method shown in FIGS. 8A-08Dsecured to the nasal septum illustrating segments of suture that areavailable for cutting.

FIG. 9 is a perspective view showing a method for using a cuttinginstrument (i.e., a pair of surgical scissors) to cut a suture holdingan embodiment of a nasal splint against the nasal septum.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Before the exemplary embodiments are described, it is to be understoodthat this invention is not limited to particular embodiments described,as such may, of course, vary. It is also to be understood that theterminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the embodiments described, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the embodiments described.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the devices and methods herein belong. Although anymethods and materials similar or equivalent to those described hereinmay be used in the practice or testing of the devices and methodsherein, some potential and preferred methods and materials are nowdescribed. All publications mentioned herein are incorporated herein byreference to disclose and describe the methods and/or materials inconnection with which the publications are cited. It is understood thatthe present disclosure supersedes any disclosure of an incorporatedpublication to the extent there is a contradiction.

It must be noted that as used herein and in the appended claims, thesingular forms “a,” “an,” and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “acompound” includes a plurality of such compounds and reference to “thepolymer” includes reference to one or more polymers and equivalentsthereof known to those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the devices and methodsdescribed and claimed herein are not entitled to antedate suchpublication. Further, the dates of publication provided may be differentfrom the actual publication dates, which may need to be independentlyconfirmed.

FIG. 1 is a perspective view of an exemplary embodiment of a nasalsplint 100 that includes a member 101, tubular airway 102, and structure103. The member 101 may be a sheet formed in relatively flatconfiguration having a wall thickness and including a first outer planarsurface 104 and a second outer planar surface (not shown) locatedopposite the first outer planar surface 104. The member 101 mayoptionally include at least one hole (not shown) extending between firstouter planar surface 104 and its second outer planar surface.

The tubular airway 102 is configured as an elongated component having awall joined to the first outer planar surface 104 or sharing a wall withthe member 101 and positioned in such a way that it is substantiallyparallel to the first outer planar surface 104 of the member 101. Thetubular airway 102 is also aligned in a direction along a longitudinalaxis extending from a first end 101′ of the member 101 to a second end101″ of the member 101. The tubular airway 102 may further include atleast one lumen 105 extending through the tubular airway 102. Thetubular airway 102 may be formed in various shapes, such assubstantially circular, semi-circular, oval, half oval, rectangle,square, or other shapes that provide an opening along its length.

FIG. 2 is a perspective view of the structure or suture receptacle 103of the nasal splint 100. The structure 103 may include a rim 106, lumenor aperture 107, and a suture bracket 108 extending some distance intothe lumen 107. The suture bracket 108 may include a hole 109 sized toaccommodate various sizes of suture needles and gages or diameters ofsuture thread. The structure 103 may further include a second hole 110disposed in the rim 106 that is generally concentrically aligned withthe hole 109 of the suture bracket 108, and is situated adjacent to thefirst outer planar surface 104 of the member 101. The hole 110 mayfurther be sized to accommodate various sizes of suture needles andgages/diameters of suture thread.

FIGS. 3A and 3B are front and top views, respectively, of a distalsection of the nasal splint 100 of FIG. 1. FIGS. 3A and 3B show thesecond outer planar surface 111 of the member 101 and a hole 112crossing through the wall of the member 101 extending between the firstouter planer surface 104 and the second outer planar surface 111. Inthis example, the hole 112 is sized similarly to and alignedconcentrically with holes 110 and 109. The space 113 between the suturebracket 108 and the rim 106 of the structure 103 may be sized tofacilitate using various cutting instruments known in the art including,but not limited to scalpels, razor/razor blades, surgical scissors, andthe like (not shown).

While the nasal splint 100 shown in FIGS. 1-3 includes holes 109, 110and 112 that are depicted as circular and of identical diameters, itshould be clear to one of skill in the art that each of these holes mayhave different sizes and/or geometries including, but not limited toellipses, polygons, and the like. Furthermore, the hole 112 may beomitted in other embodiments of the nasal splint (not shown). If thehole 112 is omitted, the material of the member 101 itself may be chosento enable penetration using a suture needle (not shown) and/or thematerial may have a thin or otherwise weakened region (not shown),thereby facilitating creating a puncture hole with the functionality ofthe hole 112 as a result of this penetration. The material may includebut not be limited to medical grade versions of silicone rubber, latex,polyurethane,

PEBAX and the like. Similarly, while the structure 103 is shown asfitting within the lumen 105 of the tubular airway 102, the structure103 may optionally be placed directly adjacent to the distal edge of thetubular airway 102, e.g., as shown in FIG. 4A, or offset distally fromthe distal edge of the tubular airway 102, e.g., as shown in FIG. 4B,which may maximize the internal cross sectional area of the tubularairway 102, as well as the cross sectional area of the lumen 107 of thestructure 103.

FIGS. 5A through 5I depict cross-sectional views of alternativeembodiments of structure 103 that may be included in a nasal splint,such as that shown in FIG. 1. In FIGS. 5A through 5I, the varyingstructures 103 are assumed to be intended for use in a nasal splint thatis to be placed in the right nasal cavity of a patient (i.e., the member101 is located to the right of the structure 103). Structures 103 thatare intended for use in a nasal splint that are to be placed in the leftnasal cavity of a patient would be mirror reflections of the depictedstructures 103 about a vertical plane located to the right of thestructures. FIG. 5A depicts holes 109 and 111 located in the rim 106 ina symmetric configuration about the midline of structure 103. FIG. 5Bdepicts holes 109 and 111 located in the rim 106 in an asymmetricconfiguration about the midline of structure 103. While FIGS. 5A and 5Bdepict holes 109 and 111 on opposite sides of the midline of structure103, it should be clear to one of skill in the art that this is merelyexemplary and the holes 109 and 111 may be located at any point aroundthe rim 106. Furthermore, it should be clear that additional holes inthe structure 103 are contemplated, and that these additional holes maybe of any size or shape, and in any location in the structure 103.

FIG. 5C depicts a hook 114 extending from the inner surface of the rim106 at a location opposite of the hole 111 in the structure 103. Theopening of the hook 114 faces the top of the structure 103, e.g., tofacilitate the placement of suture thread (not shown) over the hook 114and through the hole 111. The inclusion of the hook 114 may providebenefits to the surgeon, e.g., facilitating advancing the suture threadacross the lumen of the structure 103, as it may reduce the number oftimes the suture needle would need to traverse a hole. Looping suturethread over the hook 114 may be preferable to passing a suture needlethrough the hole 109, e.g., as depicted in FIGS. 5A and 5B.

It should be noted that other locations and orientations of the hook 114are contemplated. For example, the hook 114 may be located at anyposition within the rim 106 and/or in any orientation that facilitatesthe placement of suture thread across the lumen of the structure 103.One example is shown in FIG. 5D; in this embodiment of the structure103, the hook 114 is suspended from the interior of the rim 106 at alocation about ninety degrees (90°) relative to the hole 111 andoriented with the opening of the hook 114 facing away from the hole 111.

FIGS. 5A through 5D depict the structure 103 as a closed ringconfiguration. The use of a circular structure is beneficial in that itmay provide support to the tubular airway 107 when the suture thread iscinched or drawn tight during knot placement, e.g., preventing ormitigating collapse of either the structure 103 or the tubular airway107 when the suture thread is actively tensioned or passively maintainedin tension. Furthermore, the relatively wide lumen provides a largeaperture that the suture thread is required to cross; this presents thesurgeon with a more apparent, easier target to access and cut when thenasal splint is ready to be removed.

Other geometries of structure 103 are contemplated, such as that shownin FIG. 5E. The configuration of the structure 103 shown in FIG. 5E isgenerally semi-circular in shape, with the inclusion of a suture bracket115 extending inward from the internal surface of the rim 106 andincluding a hole 116. The suture bracket 115 is located at the midlineof the structure 103 and shown to be extending towards the center pointof the semi-circular rim 106. It is also contemplated that the suturebracket 115 may be located at any position within the boundary of therim 106, and/or that the suture bracket 115 may also extend radiallytowards the center of the semi-circle outlined by the rim 106 or mayextend towards the open space or area covered (or encased) within therim 106. It should be clear to one of skill in the art that the suturebracket 115 may extend any distance towards the center or open space ofstructure 103. The rim 106 further includes a hole 117 located near oneof the end of the rim 106. While the holes 116 and 117 are depicted atsimilar in size and shape, it should be clear to one of skill in the artthat the holes 116 and 117 may vary in size and or shape independentlyof each other. Likewise, the location of the hole 116 in the suturebracket 115 and the location of the hole 117 in the rim 106 may varyfrom that shown in FIG. 5E. For example, the embodiment of FIG. 5F isidentical to FIG. 5E, except that the configuration of the rim 106 is aquadrant.

FIG. 5G depicts a cross-section of another exemplary structure 103 wherethe rim 106 is an arc greater than a semi-circle. The structure 103further includes a suture bracket 115 extending inward from the internalsurface of the rim 106 and further including a hole 116. The suturebracket 115 is located to the right of the midline of the rim 106 and isdepicted as projecting towards the end of the rim 106. The rim 106further includes a hole 117 located near one end of the suture bracket115. While the holes 116 and 117 are depicted as similar in size andshape, it should be clear to one of skill in the art that the holes 116and 117 may have different sizes and/or shapes than each other.Likewise, the location of the hole 116 in the suture bracket 115 and thelocation of the hole 117 in the rim 106 may vary from that shown in FIG.5G.

FIG. 5H depicts an exemplary configuration of a structure 103 where therim 106 approximates the general shape of the letter “D”, with the flatside of the rim 106 substantially parallel to the member 101 (e.g., asshown in FIGS. 1 and 2). The structure 103 further includes a suturebracket 115 extending inward from the internal surface of the rim 106and further including a hole 116. The rim 106 further includes a hole117 located to the right of the suture bracket 115. While the holes 116and 117 are depicted as similar in size and shape, it should be clear toone of skill in the art that holes 116 and 117 may have different sizesand/or shapes than each other. Likewise, the location of the hole 116 inthe suture bracket 115 and the location of the hole 117 in the rim 106may vary from that shown in FIG. 5H.

FIG. SI depicts a cross-section of another exemplary structure 103 wherethe rim 106 generally approximates the shape of the letter “D,” with theflat side of the rim 106 substantially parallel to the member 101 (notshown). The structure 103 further includes a suture bracket 115extending inward from the internal surface of the rim 106 and furtherincluding a hole 116. The rim 106 further includes a hole 117 locatedalong the flat side of the structure 103. In this embodiment, the hole117 is larger than the hole 116, and may be circular, channel-like, orsome other shape.

It should be noted that the features described for one particularembodiment of the structure 103 (e.g., the hook 114 shown in FIG. 5C)may be combined with any of the other features or structures 103described elsewhere herein. For example, a feature such as the hook 114shown in FIG. 5C may replace the hole 116 in FIG. 5F. All permutationsof shapes and sizes of the structure 103, holes, hooks, features andother elements of the structure 103 are contemplated.

FIG. 6A depicts a perspective view of the distal portion of anotherexemplary embodiment of a nasal splint 200 including a member 201,tubular airway 202, and structure 203. The member 201 may include asheet formed in relatively flat configuration having a wall thicknesswith a first outer planar surface 204 and a second outer planar surface(not shown) located opposite the first outer planer surface 204. Themember 201 further includes holes 205 and 206 extending between thefirst outer planar surface 204 and the second outer planar surface (notshown). The tubular airway 202 may be constructed and/or configuredsimilar to other embodiments herein, such as that shown in FIGS. 1 and2.

The structure 203 resides within the lumen 207 of and is joined to thetubular airway 202. In this embodiment, the structure 203 is a closedtube extending in an arc that conforms to the cross-section of thetubular airway 202, e.g., originating from the base end of the tubularairway 202 and terminating at a length that fills the quadrant of theinterior surface of the tubular airway 202, and sized to accept standardsizes of suture needles. The hole 205 is concentrically aligned with theend opening of the structure 203 and the hole 206 is located near thedistal end of the tubular airway 202.

While the hole 206 is depicted as being larger in diameter than the hole205, it should be noted that the sizes of the holes 205 and 206 may bedifferent than one another. Also, while the holes 205 and 206 areillustrated to be circular in shape, other shapes may be providedincluding but not limited to ellipses, polygons, and the like arecontemplated. Furthermore, while FIG. 6A shows a pair of holes 205 and206, embodiments of the nasal splint 200 are contemplated that havezero, one, or more holes in the member 201. In an exemplary embodimentwith zero holes, it is contemplated that the member 201 may beconstructed from materials and/or may include thinner or weaker regions(not shown) that enable penetration by suture needles with suture,wherein the functionality provided by the hole 206 may be provided bythe hole created by the needle penetration.

FIG. 6B depicts a perspective view of the distal portion of anotherexample of a nasal splint 200 including a member 201, tubular airway202, and structure 203, generally similar to that described withreference to FIG. 6A. In this example, the structure 203 is larger andsituated at the distal edge and directly adjacent to the tubular airway202. This orientation (in comparison to the example shown in FIG. 6A)increases the space in the lumen of the tubular airway 202, e.g.,allowing improved (i.e., less restricted) passage of air through thelumen when the patient receiving the nasal splint breathes.

The member 201 further includes holes 205 and 206 extending through thewall between the first outer planer surface 204 and the second outerplanar surface (not shown). The hole 205 is concentrically aligned withthe end opening of the structure 203. The hole 206 is located in themember 201 such that a line drawn perpendicular to the bottom opening ofthe structure 203 passes through the center point of the hole 206.

FIG. 7A depicts a perspective view of the distal portion of stillanother embodiment of a nasal splint 300 including a member 301, tubularairway 302, and structure 303. The member 301 is a sheet formed inrelatively flat configuration having a wall thickness and comprises afirst outer planar surface 304 and a second outer planar surface (notshown) located opposite the first outer planer surface 304, and a hole307 situated distal to the structure 303 and crossing through the wallof the member 301.

The tubular airway 302 is configured as an elongated component having awall joined to the first outer planar surface 304 and situated such thatit is substantially parallel to the member 301. The tubular airway 302is also aligned at a direction along a longitudinal axis extending froma first end of the member 301 to a second end of member 301 (not shown).The structure 303 is a U-shaped bracket further including holes 305 and306. The structure 303 is offset distally from the distal end of thetubular airway 302 and joined to the member 301 such that the holes 305and 306 are substantially perpendicular to the first outer planarsurface 304 of the member 301. While the holes 305, 306, and 307 areillustrated to be circular in shape, other shapes may be providedincluding but not limited to ellipses, polygons, and the like. While themember 301 is shown with a single through hole 307, it should be notedthat the incorporation of additional holes into the member 301 is alsocontemplated.

FIGS. 7B and 7C depict front and side views, respectively, of thestructure 303 shown in FIG. 7A.

It should be clear to one of skill in the art that various permutationsof the examples shown are contemplated, such as a combination of themember 301 and structure 303 shown in FIGS. 7A through 7C with thetubular airway 102 shown in FIGS. 1-4. Any combination of member,tubular airway, and structure disclosed herein are contemplated.

FIGS. 8A-8E depict top views of a pair of exemplary nasal splints 300′and 300″ (which may be any of the embodiments herein) as they may beused to stabilize the nasal septum 400 after a procedure, such as aseptoplasty. FIG. 8A depicts the two nasal splints 300′ and 300″ inposition on the right side and left side of the nasal septum 400,respectively, and a suture needle (not shown for clarity) with a lengthof suture thread 401. FIG. 8B shows the suture thread 401 drawn throughthe proximal set of holes in the right nasal splint 300,′ across thenasal septum 400, and out the proximal set of holes in the left nasalsplint 300.″ FIG. 8C shows the suture thread 401 reversed and returnedto the opposite side through the distal hole in the left nasal splint300,″ across the nasal septum 400, and out of the distal hole in theright nasal splint 301.′

FIG. 8D shows the end result when a knot (not shown) is cinched ortensioned using the suture thread 401 to hold or secure the nasalsplints 301′ and 301″ in the nasal cavity to provide post-surgicalsplinting and support of the nasal septum 400. FIG. 8E is a magnifiedview of FIG. 8D showing four elevated and/or exposed/accessible segments402, 403, 404, and 405 of suture 401 that are available to be cut whenthe nasal splints 300′ and 300″ are ready to be removed from the patientat follow up.

FIG. 9 depicts a perspective view of an exemplary nasal splint 200(e.g., the nasal splint shown in FIG. 6A and 6B) placed in positionagainst the nasal septum 901 (indicated by the hashed background) andsecured in place with suture 902. In this illustration, a cuttinginstrument 903 may be oriented about suture 902 to allow it to be cut orreleased when the nasal splint 200 is ready to be removed at follow up.While FIG. 9 depicts the cutting instrument 903 as a pair of surgicalscissors, it should be clear to once of skill in the art that anyimplement capable of cutting the suture 902 may be used to perform thatfunction.

The preceding merely illustrates the principles of the invention. Itwill be appreciated that those skilled in the art will be able to devisevarious arrangements which, although not explicitly described or shownherein, embody the principles of the inventions and are included withinits scope. Furthermore, all examples and conditional language recitedherein are principally intended to aid the reader in understanding theprinciples of the inventions and the concepts contributed by theinventors to furthering the art, and are to be construed as beingwithout limitation to such specifically recited examples and conditions.Moreover, all statements herein reciting principles, aspects, andembodiments of the inventions as well as specific examples thereof, areintended to encompass both structural and functional equivalentsthereof. Additionally, it is intended that such equivalents include bothcurrently known equivalents and equivalents developed in the future,i.e., any elements developed that perform the same function, regardlessof structure. The scope of the present invention, therefore, is notintended to be limited to the exemplary embodiments shown and describedherein. Rather, the scope of present invention is embodied by theappended claims.

1. A nasal splint, comprising: an elongate generally planar membercomprising first and second ends, and a first outer surface and anopposite second outer surface extending between the first and secondends; a tubular airway extending along the first outer surface at leastpartially between the first and second ends, thereby defining a lumenhaving an opening adjacent the first end; and a structure on one of theelongate member and the tubular airway adjacent the first end supportinga feature that is spaced apart from the first outer surface andconfigured to support a suture at least partially across the openingwhen the suture is directed through the elongate member adjacent thefirst end to the feature.
 2. The nasal splint of claim 1, wherein thestructure comprises a tubular segment connected to the tubular airwayadjacent the opening, and wherein the feature is an opening in thetubular segment spaced at least partially across the opening from thefirst outer surface.
 3. The nasal splint of claim 2, wherein the tubularsegment is sized to accommodate a suture needle.
 4. The nasal splint ofclaim 1, wherein the structure comprises an annular ridge connected tothe first outer surface of the elongate member.
 5. The nasal splint ofclaim 1, wherein the structure has a rigidity greater than the tubularairway.
 6. The nasal splint of claim 1, wherein the elongate member issufficiently rigid to prevent substantial deformation due to suturing.7. The nasal splint of claim 1, wherein the structure comprises one ormore holes therethrough.
 8. The nasal splint of claim 7, wherein thestructure comprises two holes.
 9. The nasal splint of claim 7, whereinthe one or more holes are sized to receive a suture needle therethrough.10. The nasal splint of claim 1, wherein the feature comprises a hook.11. The nasal splint of claim 1, wherein the structure is located withinthe tubular airway adjacent the opening.
 12. The nasal splint of claim1, wherein the structure is located on the tubular airway adjacent theopening.
 13. The nasal splint of claim 1, wherein the elongate memberfurther comprises a first hole extending between the first and secondouter surfaces.
 14. The nasal splint of claim 13, wherein the first holeis in line with the opening.
 15. The nasal splint of claim 13, whereinthe feature comprises a bracket including a second hole aligned with thefirst hole.
 16. The nasal splint of claim 1, wherein the featurecomprises a hole through the structure that is spaced apart from thefirst outer surface.
 17. The nasal splint of claim 16, furthercomprising a hole through the elongate member aligned with the holethrough the structure such that a suture received through the holesextends at least partially across the opening.
 18. A nasal splint,comprising: an elongate generally planar member comprising first andsecond ends, and a first outer surface and an opposite second outersurface extending between the first and second ends; a tubular airwayextending along the first outer surface at least partially between thefirst and second ends, thereby defining an airway lumen having anopening adjacent the first end; and a protrusion extending from thetubular airway adjacent the first end such that a free end of theprotrusion is spaced apart from the first outer surface to support asuture at least partially across the opening when the suture is directedthrough the elongate member. 19-23. (canceled)
 24. A method for treatinga patient, comprising: inserting a nasal splint into the patient'ssinus, the nasal splint comprising an elongate planar member and anairway lumen extending along a first surface of the elongate member;positioning a second surface of the elongate member against the sinusseptum such that the airway lumen extends along the patient's sinus; anddirecting a suture through the patient's septum, the elongate member,and a structure on the nasal splint such that the suture extends acrossa portion of the airway lumen.
 25. The method of claim 24, furthercomprising: inserting a cutting instrument into the portion of theairway lumen; cutting the suture; and removing the nasal splint. 26-51.(canceled)